Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe, a High-dose Quadrivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Sanofi
- 入组人数
- 670
- 试验地点
- 1
- 主要终点
- Occurrence of solicited (pre-listed in the participant's diary card [DC] and case report form) injection site and systemic reactions
研究概览
简要总结
To investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda Tetra in adults aged 65 years or older under routine clinical practice, as per approved indications.
The study duration of each participation will be approximately 28 to 35 days. In the event that Visit 2 is not made, the study duration would be extended to 36 to 42 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 65 years or older on the day of enrollment
- •The informed consent form has been signed and dated
- •Receipt of 1 dose of Efluelda Tetra on the day of enrollment according to the approved local product label
排除标准
- •Previous history of enrollment in this study
- •Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure
研究组 & 干预措施
Efluelda group
A single dose of 0.7 mL is administered as approved by MFDS.
干预措施: Efluelda Tetra Pre-filled syringe (Biological)
结局指标
主要结局
Occurrence of solicited (pre-listed in the participant's diary card [DC] and case report form) injection site and systemic reactions
时间窗: From baseline up to 7 days after vaccination
Occurrence of unsolicited AEs and ADRs
时间窗: From baseline up to Visit 2 (28-35 days) after vaccination
Occurrence of unexpected AEs and ADRs
时间窗: From baseline up to participant's last contact after vaccination (36-42 days)
Occurrence of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)
时间窗: From baseline up to participant's last contact after vaccination (36-42 days)
Occurrence of AE of special interest (AESI)
时间窗: From baseline up to participant's last contact after vaccination (36-42 days)
次要结局
未报告次要终点